Applicant's summary and conclusion

The test item is not classified according to Directive 67/548/EEC and CLP Regulation (EC) n° 1272/2008.

Executive summary:

In a Magnusson & Kligman maximisation study (GPMT) performed according to OECD guideline 406 and in compliance with GLP, groups of 20 female albino Dunkin-Hartley guinea pigs were intradermally induced with three injections of 0.1 mL of FCA, 10% w/v of test item in arachis oil and 10% w/v of test item emulsion in FCA on Day 0 on shoulder region on each side of mid-line. Control group of 10 animals was induced with FCA, arachis oil and 50% w/v arachis oil in FCA intradermal injections. After one week the same area was topically induced with 0.2-0.3 mL of undiluted test material via occluded filter paper patch for 48 hours for the treated group. Control group was patched with nothing applied to the filter paper. After 2 weeks of rest period, a challenge patch of 0 or 75% v/v test material in absolute ethanol was applied to left or right shorn flank of all animals, respectively. The test concentrations for the main study were determined from a sighting study using one or two animals.

Intradermal and topical induction indicated evidence of dermal irritation. No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48-hour observations. The test item produced a 0% (0/20) sensitisation rate and was considered to be a nonsensitiser to guinea pig skin. Historical data on positive control (40% formaldehyde) exhibited evidence of sensitisation.

Therefore, the test item is not classified according to Directive 67/548/EEC and CLP Regulation (EC) n° 1272/2008.

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